IceCure Medical Ltd. (NASDAQ: ICCM) Q1 2025 Earnings Call | 05/28/2025

IceCure Medical Ltd. Q1 2025 Financial Results and Strategic FDA Update

IceCure Medical Ltd., a company specializing in cryoablation technology, held its conference call to discuss the financial results for the first quarter ended March 31, 2025, and provide an update on its recent operational highlights, particularly concerning its engagement with the FDA for ProSense in early-stage breast cancer treatment.

Key Highlights:

• Positive FDA Meeting for ProSense: IceCure Medical met with the FDA's Center for Devices and Radiological Health (CDRH) in late April to discuss marketing authorization for its ProSense cryoablation system for early-stage, low-risk breast cancer in women aged 70 and over (a demographic representing approximately 46,000 U.S. patients annually).
• Post-Market Study Request: The FDA requested IceCure Medical to conduct a post-market study after marketing authorization is granted, which the company views as a positive signal. IceCure Medical has since submitted the post-market study plan to the CDRH for review and comments, hoping this is the final step before FDA approval.
• Commercial Launch Plans: Upon FDA marketing authorization, IceCure Medical plans to commence commercial sales for this indication in parallel with running the post-market study. This would allow access to reimbursement under the CPT-3 code, covering $3,800 for treatment facility costs. The company believes additional reimbursement may become available based on regulatory approval and recommendations from medical associations, with plans to apply for a CPT-1 code (including physician fees) from the AMA.
• Positive Industry Reception: The FDA's request for a post-market plan was well-received at the American Society of Breast Surgeons 2025 Annual Meeting in early May, where there was high interest from breast surgeons to participate in the study and offer ProSense to patients. ProSense and IceCure Medical's "ice ring study" were featured prominently at the meeting.
• Financial Performance (Q1 2025):
  • Revenue: $725,000 from ProSense system and disposable probe sales, a slight decrease from $743,000 in Q1 2024. Revenue growth was seen in North America and Europe, offset by a decline in Asia.
  • Gross Profit: $218,000, with a gross margin of 30%.
  • Net Loss: $3.59 million, or $0.06 per share, compared to $3.61 million (or $0.08 per share) in Q1 2024.
  • Cash Position: Approximately $6.2 million in cash and cash equivalents as of May 27, 2025, including a $2 million unsecured bridge loan from Epoch Partner Investor Limited (the largest shareholder).
• Future Catalysts: Beyond the FDA decision, IceCure Medical looks forward to potential regulatory filings and approvals in Japan and Israel later in 2025.
• Commercial Strategy: Once approved, IceCure Medical plans to expand its U.S. sales team and employ a commercial model that balances console sales (50-60%) with placements (40-50%) tied to commitments for monthly probe usage at a higher price.